New Daily Pill for Adult Muscle and Skin Inflammation

Lisraya (brepocitinib; pronounced liss-rye-uh) is a once-daily oral tablet that inhibits TYK2 and JAK1 — Janus kinase pathways that help drive the inflammation of dermatomyositis. It is not intravenous immunoglobulin (IVIg). It is not a corticosteroid. It is not methotrexate, mycophenolate, or azathioprine. It is not a cure.

The FDA labelled it on 27 August 2026 for the treatment of dermatomyositis in adults. The labelled dose is 30 mg by mouth once a day, with or without food. It is the first oral medicine specifically indicated for adult dermatomyositis on the U.S. novel-drug list (No. 35 for 2026).

Health Canada’s Notice of Compliance was not retrieved — Canada is not dual-approved and has no NOC on the record used here. Europe has an orphan designation only (no marketing authorisation retrieved). The UK, Australia, Japan, China, and Switzerland authorisations were not retrieved.

This is not labelled for children. It carries a boxed warning shared with the JAK-inhibitor class. It does not replace the need to manage infection risk, cardiovascular risk, clotting risk, cancer screening, pregnancy planning, and the background therapies your rheumatology or dermatology team already set.

Where this is taking place

Week 52 pivotal readouts are done. VALOR remains ACTIVE_NOT_RECRUITING on ClinicalTrials.gov because the open-label extension / follow-up window was still estimated toward July 2026. That is not a new first-script enrolment slot. Access in the United States is a commercial prescription through a clinician; company materials also describe limited specialty-pharmacy distribution (company claim — not a labelled Access door).

VALOR (NCT05437263) — Phase 3, randomized, double-blind, multicenter, placebo-controlled, then optional open-label extension. Adults with dermatomyositis. Sponsor: Priovant Therapeutics, Inc. Enrollment: 241 (actual). Status: ACTIVE_NOT_RECRUITING. hasExpandedAccess: false — no EAP. Primary completion 17 Jul 2025. Estimated completion Jul 2026. Arms: brepocitinib 30 mg once daily (labelled), 15 mg once daily (unapproved dosage on the USPI), or placebo for 52 weeks. Primary endpoint: Total Improvement Score (TIS) at Week 52. Not an enrolment door.

Canadian sites on CT.gov (historical — not recruiting, not a DIN, not an enrolment door):

• Clinical Trial Site — Vancouver, British Columbia
• Clinical Trial Site — Newmarket, Ontario

These addresses are historical trial sites, not a walk-in clinic directory, and not a commercial Canadian product. CT.gov does not name a site principal investigator for either. Overall study status ACTIVE_NOT_RECRUITING and hasExpandedAccess: false.

Other brepocitinib trials (different diseases — not this labelled DM door, not EAP for DM):

• Lichen planopilaris NCT07532603 — RECRUITING, with Canadian sites (Edmonton AB; Guelph ON; London ON; Toronto ON ×2). This is LPP research only — not a Lisraya dermatomyositis access door and not expanded access for DM.
• Cutaneous sarcoidosis NCT06978725 — RECRUITING, US-only (no Canadian sites). Not the DM label.

Commercial supply (labelled): United States. Canada: no retrieved NOC. EMA: orphan designation only — no marketing authorisation. UK / Australia / Japan / China / Switzerland: authorisation not retrieved.

Approval matrix

Access by country

• United States: Rheumatology and/or dermatology clinician experienced in idiopathic inflammatory myopathies. FDA-labelled 27 Aug 2026 for adults with dermatomyositis. One 30 mg tablet once daily, with or without food. Pink tablet debossed BT30. Before start: TB testing, viral hepatitis screening, CBC, liver and kidney labs, pregnancy status if of reproductive potential, and up-to-date immunizations (no live vaccines while on treatment). Do not combine with another JAK inhibitor, another TYK2 inhibitor, or a biologic DMARD. Background steroids, conventional immunosuppressants, and IVIg were allowed in the pivotal trial at stable doses — your clinician decides the combination. Labelled contacts (USPI): Priovant medical information / pregnancy registry / AE reporting 1-800-511-9141; Medication Guide www.LISRAYA.com; pregnancy reports also contactcenter@priovant.com; FDA MedWatch 1-800-FDA-1088. Company materials separately describe limited specialty-pharmacy distribution, My Compass Support, and a wholesale list price near $35,000 per 30-day bottle — those are company claims, not labelled Access doors; WAC is not your bill. No copay dollars here. Prior authorization still applies. Children not established.

• Canada (zoom, not a different Access Level): No retrieved NOC — Canada is not dual-approved. A specialist can ask about Health Canada Special Access Programme for a non-marketed drug when conventional therapy has failed, is unsuitable, or is unavailable — the manufacturer must agree to supply. SAP status is unknown. VALOR Canadian sites above are historical; the trial is not recruiting and has no expanded access on CT.gov — not an enrolment door. The recruiting lichen planopilaris trial (NCT07532603) at Edmonton, Guelph, London, and Toronto×2 is LPP research only — not a Lisraya dermatomyositis access door. Provincial / territorial / NIHB / RAMQ listing is N/A until there is a NOC. Do not mail-order a US bottle as the plan. This zoom is not the Access Level.

• European Union: Orphan designation EU/3/25/3121 (idiopathic inflammatory myopathy; Scendea NL; 22 Aug 2025) only — no marketing authorisation retrieved. Specialist + local special-access / named-patient / trial only if those programs apply. Do not DIY-import a US bottle.

• United Kingdom / Australia / Japan / China / Switzerland: Authorisation not retrieved. Specialist + local special-access / named-patient / trial only if those programs apply. Do not DIY-import a US bottle.

If your regulator has not authorised it: do not import on your own.

Who is eligible (from the USPI)

United States (USPI):

• Adults with dermatomyositis.
• Dose: 30 mg orally once daily, with or without food.
• Not recommended with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.
• Not recommended if eGFR <30 mL/min or Child-Pugh C.
• Avoid start (and interrupt) if ALC <500 cells/mm³, ANC <1,000 cells/mm³, or hemoglobin <8 g/dL.
• Not recommended in active hepatitis B or hepatitis C.
• Avoid use during an active serious infection.
• Contraindicated if hypersensitivity to brepocitinib or any tablet ingredient (tablet contains lactose monohydrate).
• Pediatrics: not established.
• Females of reproductive potential: pregnancy test before start; effective contraception during treatment and for 3 days after the last dose; do not breastfeed during treatment and for 3 days after the last dose.

How VALOR was built (context for your clinician — not a second indication sentence): 2017 EULAR/ACR dermatomyositis classification; ages 18–75 on CT.gov; active muscle and skin disease; prior or current corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant; weight and BMI gates; exclusions included end-stage organ involvement, irreversible muscle disease, recent cancer (with listed exceptions), cancer-associated DM, many overlap CTDs, high thrombosis/CV risk, high herpes-zoster risk, and active/recent infections.

Not the labelled US door:

• Children / juvenile dermatomyositis.
• A Canadian DIN (none retrieved).
• “Join VALOR” as a way to start — the trial is ACTIVE_NOT_RECRUITING, hasExpandedAccess false, and is not an enrolment door.
• Other-disease brepocitinib trials as a DM script: NCT07532603 (lichen planopilaris, recruiting with CA sites) is LPP research only; NCT06978725 (cutaneous sarcoidosis, recruiting, US-only) is not the DM label.

What VALOR showed (use the USPI)

These numbers are from the USPI clinical studies section (Trial DM / NCT05437263), not from a press release alone.

Primary — LS mean Total Improvement Score at Week 52:

• Lisraya 30 mg 47.5 vs placebo 33.3
• Difference 14.2 (95% CI 5.5, 22.9)

TIS response rates at Week 52:

• TIS ≥20: 82% vs 63%
• TIS ≥40: 69% vs 47%
• TIS ≥60 (major improvement): 48% vs 26%

Core set measures (LS mean change, Week 52 — direction favors Lisraya on PhGA, PtGA, EMGA, MMT-8, HAQ-DI): skin/extramuscular and patient/physician globals improved more on Lisraya; muscle strength (MMT-8) improved more; physical function (HAQ-DI) improved on Lisraya vs worsened slightly on placebo. Muscle-enzyme change favored Lisraya but the confidence interval crossed zero.

Steroid sparing: among people on oral corticosteroids at baseline (76%; mean ~11.4 mg/day prednisone-equivalent), 55% on Lisraya vs 30% on placebo achieved TIS ≥40 with minimal-to-no steroids (≤2.5 mg/day) at Week 52.

Trial population (USPI): mostly female (78%), White (72%), mean age 51; 65% had ≥1 cardiovascular risk factor or atherosclerotic disease history; 20% had interstitial lung disease. Background therapies continued at stable dose: oral steroids 76%, non-steroid immunosuppressants 72%, antimalarials 27%.

This is better composite disease control and more steroid sparing over 52 weeks. It is not a proven survival benefit or a cure. Use the USPI tables for a U.S. clinic script.

How it is taken (US label)

• 30 mg once daily by mouth, with or without food.
• Pink, capsule-shaped, film-coated tablet debossed BT30.
• Store below 30 °C (86 °F).
• If a serious infection develops, interrupt until the infection resolves or is adequately treated.
• Lab interruptions: ANC <1,000; ALC <500; Hb <8 g/dL; interrupt if drug-induced liver injury is suspected until excluded.
• Do not stack with another JAK or TYK2 inhibitor or a biologic DMARD.
• Smoking may lower exposure — tell your clinician if you smoke; effectiveness may be reduced.
• Missed-dose detail is not a separate boxed algorithm on the Medication Guide beyond taking as prescribed — ask the pharmacy/clinic for their written instructions.

Safety (from the USPI)

Boxed warning — read this with your clinician before the first tablet:

• Serious infections (bacterial, fungal, viral, opportunistic), including TB, that can lead to hospitalisation or death. Most common serious infections in Trial DM: pneumonia and sepsis. Herpes zoster / viral reactivation reported. Test for TB; treat latent TB before start; watch for infection symptoms.
• Mortality — higher all-cause mortality (including sudden cardiovascular death) seen with another JAK inhibitor vs TNF blockers in older RA patients with CV risk. Lisraya is not approved for RA.
• Malignancy — cancers have occurred; higher rates of certain cancers (including lymphoma and lung cancer in smokers) seen with another JAK inhibitor vs TNF blockers in RA. Limit UV; skin checks if at risk.
• MACE (CV death, MI, stroke) — observed on Lisraya; higher MACE with another JAK inhibitor vs TNF blockers in RA. Extra risk if current/past smoker. Stop after MI or stroke.
• Thrombosis (DVT, PE, arterial) — can be serious or fatal. Avoid if at increased thrombosis risk; stop and evaluate if clot symptoms appear.

Other labelled warnings: hypersensitivity (stop for significant reaction); GI perforation (higher concern with diverticulitis history, NSAIDs, steroids — new severe abdominal pain needs urgent evaluation); hypoglycemia in people with diabetes; lab abnormalities (neutropenia, lymphopenia, anemia, lipids, liver enzymes — get GGT too because AST/ALT can reflect muscle disease); live vaccines; embryofetal toxicity.

Most common adverse reactions (≥5% and ≥2% greater than placebo): upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, acne.

Serious infections in Trial DM (52 weeks): 10% on Lisraya vs 1% on placebo. Viral reactivations (all herpes zoster in the labelled arm context): 5% on Lisraya.

Geriatrics: 17% of Lisraya-treated patients were ≥65; serious adverse events were higher in older adults; viral reactivation rates were higher ≥65.

Report side effects: Priovant 1-800-511-9141 or FDA 1-800-FDA-1088 / www.fda.gov/medwatch.

Research team (Who)

Names below are as they appear on primary sources.

• Priovant Therapeutics, Inc., Durham, NC — FDA approval granted to; USPI “Manufactured for”; NDA packager; VALOR lead sponsor. USPI contacts: 1-800-511-9141 / contactcenter@priovant.com (pregnancy safety study); Medication Guide www.LISRAYA.com.
• Roivant Sciences — parent company announcing FDA approval / commercial materials (company source).
• Pfizer origin — molecule licensed into Priovant / Roivant (company / trade reporting; not a second regulatory applicant on the USPI).
• Scendea (NL) B.V. — EMA orphan designation holder for EU/3/25/3121 (idiopathic inflammatory myopathy) — orphan only, not an MA holder for Lisraya.
• FDA press quotes Nikolay Nikolov, M.D., Director, Office of Immunology and Inflammation, CDER — regulator, not a treating clinic.
• VALOR NCT05437263: CT.gov lists no overall official and no named Canadian site investigators.

Company patient-support materials (not the USPI medical line; company claim, demoted): My Compass Support — 1-888-736-9788 / mycompasssupport@priovant.com — coverage navigation, not a labelled Access door and not a guarantee of any dollar amount.

How to talk to a doctor

Bring the NCT number and the regulator that applies:

1. “I have adult dermatomyositis. The FDA labelled brepocitinib (Lisraya) on 27 August 2026 as a 30 mg once-daily oral TYK2/JAK1 inhibitor. Is that a fit with my skin and muscle disease and my current steroids / methotrexate / mycophenolate / IVIg plan?”
2. Boxed warning: “The label has JAK-class warnings for infection, death risk, cancer, heart events, and clots. Given my age, smoking history, clotting history, and cancer screening, how do we weigh that?”
3. Baseline workup: “Can we schedule TB testing, hepatitis screening, CBC, liver (including GGT), kidney labs, vaccines (no live vaccines after start), and pregnancy testing if needed before the first tablet?”
4. Combinations: “The label says not with other JAK/TYK2 inhibitors or biologic DMARDs — what stays, what stops?”
5. Monitoring: “Who orders follow-up labs and lipid check around 12 weeks? What infection symptoms mean I should call the same day?”
6. Access: “Can we use the USPI contacts — Priovant 1-800-511-9141, www.LISRAYA.com, and MedWatch if needed — and how does the clinic handle specialty pharmacy and prior authorization?”
7. If Canada: “Is there a Health Canada NOC yet? If not, is SAP appropriate, or do we wait? VALOR Canadian sites are not recruiting and CT.gov shows no expanded access. The recruiting LPP trial at Canadian sites is not a dermatomyositis access door.”
8. If outside the US: “Has my regulator authorised it (EMA has orphan designation only — not a marketing authorisation), or are we looking at special access / travel with both specialists?”
9. Steroids: “VALOR showed more people reaching improvement with ≤2.5 mg/day steroids — what taper plan is safe for me?”

Canada zoom: no NOC / not dual-approved

Health Canada NOC was not retrieved — Canada is not dual-approved and has no NOC on the record used here. SAP for a non-marketed drug is unknown. Provinces are N/A until NOC. US: labelled Rx with boxed JAK-class warnings. VALOR Canadian sites (Vancouver BC; Newmarket ON) are historical and not recruiting; hasExpandedAccess false — not an enrolment door. Recruiting NCT07532603 Canadian sites are lichen planopilaris research only, not Lisraya DM access. No expanded access on CT.gov. Do not mail-order.

Bottom line

Lisraya (brepocitinib) is a once-daily 30 mg oral TYK2/JAK1 inhibitor labelled in the United States on 27 August 2026 for dermatomyositis in adults, with a boxed warning for serious infections, mortality, malignancy, MACE, and thrombosis. In VALOR, Week 52 mean TIS was 47.5 vs 33.3 on placebo (USPI). Canada: NOC not retrieved — not dual-approved; not a Health Canada/FDA Access Level. EMA: orphan EU/3/25/3121 only — no MA. VALOR is ACTIVE_NOT_RECRUITING with no EAP. Open LPP and cutaneous-sarcoidosis trials are not DM access doors. Company list price and My Compass Support are company claims, not labelled Access doors. Authorized is not funded. Canada is a zoom.

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Primary sources

1. FDA press announcement, 27 Aug 2026 — first oral drug indicated to treat dermatomyositis in adults — https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults
2. FDA Novel Drug Approvals for 2026 — Lisraya (brepocitinib), No. 35, 8/27/2026 — https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
3. DailyMed LISRAYA (brepocitinib) tablets USPI / Medication Guide, setid 5023a17b-e96a-67d4-e063-6394a90a14a7, NDA 220106, revised 8/2026, marketing start 08/27/2026 — https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5023a17b-e96a-67d4-e063-6394a90a14a7&version=3
4. ClinicalTrials.gov NCT05437263 VALOR — https://clinicaltrials.gov/study/NCT05437263
5. EU Community Register of orphan medicinal products — EU/3/25/3121 brepocitinib, designated 22 Aug 2025, treatment of idiopathic inflammatory myopathy, Scendea (NL) B.V. (orphan ≠ MA)
6. ClinicalTrials.gov NCT06978725 (cutaneous sarcoidosis, RECRUITING, US-only) and NCT07532603 (lichen planopilaris, RECRUITING, CA sites) — other-indication programmes only; not DM access / not EAP for DM
7. Health Canada SUR — New drug submissions under review (brepocitinib/Lisraya absent)
8. Priovant Therapeutics company approval release, 27 Aug 2026 (My Compass Support / specialty pharmacy / patient line — company claim, not the legal USPI) — https://www.globenewswire.com/news-release/2026/08/27/3352364/0/en/priovant-announces-fda-approval-of-lisraya-brepocitinib-for-adults-with-dermatomyositis-now-available-in-the-u-s.html
9. Roivant Sciences Form 8-K / investor materials citing WAC ~$35,000 per 30-count bottle (company list price ≠ patient cost; company claim)

Who (from sources)